ConformaWrap

Basic Information

• Brand Name: ConformaWrap
• Primary DI: G517CW4080
• Version / Model: CW4080
• Catalog Number: CW4080
• Company Name: Biocircuit Technologies, Inc.
• Labeler DUNS: 116978015
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-10
• Public Version: 1
• Public Version Date: 2025-09-18
• Public Version Status: New
• Public Device Record Key: 6b29af3d-992f-4b62-a2b9-43000e9e816d

Device Description

ConformaWrap is a surgical implant designed to protect a damaged peripheral nerve, serving as a non-constricting interface between the nerve and the surrounding tissue. ConformaWrap is composed of an extracellular matrix (ECM), which is fully remodeled during the healing process. When hydrated, ConformaWrap is easy to handle, soft, pliable, nonfriable, and porous. ConformaWrap is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JXI	Cuff, Nerve	Neurology	882.5275	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43233	Nerve guide, animal-derived	An implantable tubular device made exclusively of animal-derived bioabsorbable material(s) [e.g., porcine-derived collagen matrix, chitosan] intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve stumps. The device is typically used during hand surgery and/or nerve reconstruction. It is intended to be chemically degraded and typically absorbed via natural body processes. It is also known as a nerve sheath, nerve cuff, nerve protector, nerve conduit, or a nerve wrap.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G517CW4080	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	80	Millimeter
Width	40	Millimeter